A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

Completed

• Conditions: Full Thickness Rotator Cuff Tear
• Interventions: Procedure: Operative management

• Registration Number: NCT03021733
• Lead Sponsor: University of Michigan

Brief Summary

This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.

Detailed Description

This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-16
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair

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Exclusion Criteria

• less than 18 years old,
• non-operative rotator cuff tears,
• calcific tendonitis, fracture, adhesive capsulitis,
• severe osteoarthritis of the shoulder,
• no prior shoulder surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operative	Operative management	Patients whom elected operative treatment

Primary Outcome Measures

Name	Time	Method
Veterans Rand VR-12 Quality of Life Score	64 weeks